Design Control for Medical Devices – Inhouse Training

Trust is good, but control is better?

Trust in the creativity of your development team and use Design Control to guide the development process.

Do you want to develop safe and high-performance medical devices that not only meet regulatory requirements but also optimally serve market needs?

To do so, you need, above all, an outstanding development team. In addition, you need a process that does not hinder creativity and innovation, but instead harnesses and channels them in an orderly manner.

Controlling design and development (in short, development steering) is not only sensible but also required by ISO 13485 as part of quality management. It is also a prerequisite for CE marking under EU regulations (MDR 2017/745, IVDR 2017/746) or product approval in the U.S.

But what exactly is design control?

The FDA states the following in the introduction to its guidance:

Design controls are a coherent set of practices and procedures integrated into the design and development process, i.e., a system of checks and balances. Design controls make the systematic evaluation of the design an integral part of development.

In this interactive seminar, you will deepen your understanding of the medical device development process. You will learn about both European and U.S. requirements, as well as useful tools for effective design control.

Numerous illustrative examples and practical tips will help you apply these requirements to your company and your products.